Medical device makers Medtronic PLC and Boston Scientific Corp. said this week that they are not backing away from drug-eluting devices used in blood vessels in the legs, despite an analysis in a respected publication linking the devices to a significantly increased risk of death.
The Journal of the American Heart Association (JAHA) published a study-of-studies last month that found a higher risk of death after devices to open vessels above the knees in the legs were coated with a specific anti-inflammatory drug called paclitaxel.
"Further investigations are urgently warranted," the study authors concluded after synthesizing the results of 28 randomized controlled trials of stents and drug-coated balloons used above the knee in the legs.
The devices studied in the data review, called a meta-analysis, include some of the most talked-about new vascular products offered by major Minnesota device makers, including Medtronic's IN.PACT Admiral drug-coated medical balloon and Boston Scientific's Ranger drug-coated balloon. Boston Scientific's Eluvia drug-eluting stent also contains paclitaxel.
In presentations to investors this week at the J.P. Morgan Healthcare Conference in San Francisco, executives with Medtronic and Boston Scientific said they have looked deeply at their own internal data and cannot find support for the higher death rates documented in the JAHA article.
"We've generated a ton of clinical evidence: 1,800 patients, we have data out to five years, randomized controlled study for the U.S., randomized controlled clinical study for Japan, global registry data. And all of these data have been analyzed. We have not seen this safety signal in our data," Medtronic Cardiac and Vascular Group President Mike Coyle told investors Monday. (Those data are likely to be published in coming months, he said.)
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On Tuesday, Boston Scientific Global Chief Medical Officer Ian Meredith said meta-analyses like the paclitaxel-device study in JAHA sometimes reach findings that are not borne out in later studies.
Meredith also noted that the broad, study population-level data offered no explanation for the potential mechanism behind the deaths.
"I think at this stage, good clinical studies are appropriate," Meredith said. "There does not seem to be a plausible mechanism to understand how a dose that is imperceptible in plasma or tissue at 30 days could actually really affect mortality two years and beyond."
Reached via e-mail Wednesday, lead study author Dr. Konstantinos Katsanos of Rion, Greece, stood by the findings of the analysis.